Synthes, Inc., based in West Chester, PA, pleaded guilty last week to dozens of crimes for performing unauthorized bone cement tests on 200 spinal surgery patients. Synthes subsidiary, Norian Corp., pled guilty to one felony and 110 misdemeanor counts of shipping a mislabeled product. The tests were performed from 2002 to 2004. The US Food and Drug Administration (FDA) only approved the bone cement to be used in the arm, not in the spine. The June 2009 indictment states that Synthes executives put profits before safety and now four executives could be facing jail time regardless of whether or not they intended to break the law. Three spine surgery patients died on the operating table during the unauthorized tests.
In addition, the indictment explains that the company’s pilot studies showed that the Norian bone cement could cause blood clots. All the patients that died suffered from either severe hypotension or low blood pressure, following the injection of the bone cement. The performing surgeons could not rule out the product as a factor of their deaths, however, the bone cement was never ruled as the cause of death.
If you are someone you love was injected with Norian bone cement and have suffered blood clots after the injection, please contact Sheller, P.C. at 1-800-883-2299.